Thursday, March 23, 2017

I am tardy in getting this up. I guess I'm just. . . not feeling it, in truth. Memories from London do weigh on me, this early morning. [Backgrounders from June 2016, here, and a prior April 2014 one, here.]

. . . .The primary issue in this case is whether Plaintiffs’ state-law failure-to-warn claims are preempted by federal law under the Supreme Court’s decision in Wyeth. This is not a straightforward determination.
Wyeth says only that a claim is preempted when there is “clear evidence” that the FDA would not have approved a label change. This standard is cryptic and open-ended, and lower courts have struggled to make it readily administrable. This appeal, however, requires us to do so. To assess whether Merck is entitled to summary judgment on its affirmative preemption defense, we must answer two questions: What is “clear evidence”? And who should determine whether clear evidence exists?

For the following reasons, we conclude that (1) the term “clear evidence” refers solely to the applicable standard of proof, and (2) the ultimate question of whether the FDA would have rejected a label change is a question of fact for the jury rather than for the court. By describing the ultimate question as one of fact for the jury, we do not mean to suggest that summary judgment is categorically unavailable to a
manufacturer asserting a preemption defense. When there is no genuine issue of material fact — that is, when no reasonable jury applying the clear-evidence standard of proof could conclude that the FDA would have approved a label change — the manufacturer will be entitled to judgment as a matter of law. We simply hold that, at the summary judgment stage, the court cannot decide for itself whether the FDA would have rejected a change, but must instead ask whether a reasonable jury could find that the FDA would have approved the change. . . .

And. . . it looks like 45 is still considerably short of the first round of House votes he needs -- just to start the process -- for his health (non-) care abomination of a bill. [And then there's the Senate.] Now you know. Onward. I'll be decidedly Hamiltonian for a bit. . . .

More FDA Resources. . .

Blog Archive

Senator Grassley's Concern

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FDA Drug Facts

The Condor. . . .

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